Cephalalgia : an international journal of headache
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Multicenter Study Clinical Trial
Patient-reported outcomes in subjects with painful trigeminal neuralgia receiving pregabalin: evidence from medical practice in primary care settings.
Effects of pregabalin (PGB) on patient-reported health outcomes were assessed in 65 PGB-naive subjects with trigeminal neuralgia refractory to previous analgesic therapy in a prospective, multicentre observational study carried out in primary care. Twelve weeks' monotherapy with PGB (n = 36) or add-on (n = 29), reduced baseline intensity of pain by a mean +/- S. D. of -40.0 +/- 22.1 mm [-55.4%, effect size (ES) 2.32; P < 0.0001] with 59.4% of responders (pain reduction >or= 50%), and produced 34.6 +/- 29.3 additional days with no/mild pain. ⋯ PGB improved sleep by -17.9 +/- 19.6 points (ES 1.18; P < 0.0001) and improved patient functioning (Sheehan Disability Index) by decreasing overall scoring by -8.6 +/- 5.9 points (ES 1.59; P < 0.0001). Health state (EQ-5D) increased by 31.6 +/- 22.2 mm (ES 1.67; P < 0.0001), with 0.0388 +/- 0.0374 gained quality-adjusted life-years. In spite of the small sample size, results support the effectiveness of PGB for the improvement in pain and related health symptoms.
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Randomized Controlled Trial Multicenter Study
Randomized, double-blind, placebo-controlled, proof-of-concept study of the cortical spreading depression inhibiting agent tonabersat in migraine prophylaxis.
Tonabersat is a novel putative migraine prophylactic agent with an unique stereospecific binding site in the brain. Tonabersat has been shown, in animal models, to inhibit experimentally induced cortical spreading depression, the likely underlying mechanism for migraine aura, and cerebrovascular responses to trigeminal nerve stimulation. The aim was to study the potential for tonabersat as a migraine preventive. ⋯ At least one treatment-emergent adverse event was reported in the tonabersat group in 61% of patients compared with 51% in the placebo group; none was worrisome. Placebo responses were unexpectedly high in this trial, complicating straightforward interpretation of the study results. The good tolerability and promising efficacy results support further exploration of higher doses of tonabersat in larger controlled trials.
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Multicenter Study
Whites and African-Americans in headache specialty clinics respond equally well to treatment.
This study sought to determine if Whites and African-Americans respond similarly to headache treatment administered in 'real-world' headache specialty treatment clinics. Using a naturalistic, longitudinal design, 284 patients receiving treatment for headache disorders completed 30-day daily diaries that assessed headache frequency and severity at pretreatment and 6-month follow-up and also provided data on their headache disability and quality of life at pretreatment and 1-, 2- and 6-month follow-up. ⋯ Nevertheless, Africans-Americans had significantly more frequent and disabling headaches and lower quality of life after treatment relative to Whites. Although Whites and African Americans responded favourably to headache treatments, more efficacious treatments are needed given the elevated level of headache frequency that remained in both racial groups following treatment.
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Randomized Controlled Trial Multicenter Study
Headache classification by history has only limited predictive value for headache episodes treated in controlled trials with OTC analgesics.
We investigated the consistency between the headache diagnosis based on medical history and three treated headache episodes diagnosed based on a diary. In a randomized double-blind study including individuals with either migraine or tension-type headache (TTH) we showed significant superiority of the fixed combination of acetylsalicylic acid + paracetamol + caffeine over the combination without caffeine, the single preparations, and placebo in the treatment of headache. A neurologist performed a classification of the usual headache episodes and each of the three treated ones in a blinded fashion based on a structured questionnaire. ⋯ Our results demonstrate that an initial headache diagnosis does not accurately predict the headache type treated in a randomized trial. Symptom features of treated headaches should be captured to ensure that the attack is of the type targeted by the clinical trial. The International Headache Society Guidelines for controlled clinical trials should be updated accordingly.
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Randomized Controlled Trial Multicenter Study
Management of medication overuse headache: 1-year randomized multicentre open-label trial.
It is a general belief that patients with medication overuse headache (MOH) need withdrawal of acute headache medication before they respond to prophylactic medication. In this 1-year open-labelled, multicentre study intention-to-treat analyses were performed on 56 patients with MOH. These were randomly assigned to receive prophylactic treatment from the start without detoxification, undergo a standard out-patient detoxification programme without prophylactic treatment from the start, or no specific treatment (5-month follow-up). ⋯ However, the prophylaxis group had the greatest decrease in headache days compared with baseline, and also a significantly more pronounced reduction in total headache index (headache days/month x headache intensity x headache hours) at months 3 (P = 0.003) and 12 (P = 0.017) compared with the withdrawal group. At month 12, 53% of patients in the prophylaxis group had > or = 50% reduction in monthly headache days compared with 25% in the withdrawal group (P = 0.081). Early introduction of preventive treatment without a previous detoxification programme reduced total headache suffering more effectively compared with abrupt withdrawal. (ClinicalTrials.gov number, NCT00159588).